Consent

T502a – Consent Form
Version 02/14/2019 Page 1 of 3 Form date: 02/2019
“Tomorrow’s Cures Today”
Consent to Participate in Research
The University of Arizona Biorepository
Principal Investigator: David T. Harris, Ph.D.
This is a form for your consent to participate in a research project. It contains important
information about this study and what to expect if you decide to participate. Please consider
the information carefully. Feel free to discuss the study and to ask questions before making
your decision whether or not to participate.
1. Why is this study being done?
The purpose of this project is to obtain saliva as a source of DNA that will
analyzed and may be stored in a biorepository. A biorepository is a collection of
samples and health information that can be used by researchers for future studies. Studies
may be done to understand the biology and treatment of human diseases (example:
cancer, diabetes, asthma, genetic disorders, biomarkers, animal studies,
etc.). Your samples will be linked in an anonymous fashion health information that you
provide. There is the possibility that the anonymous data could be used by itself without
further consent.
Researchers inside and outside of the University of Arizona may have access to the data,
samples and the linked but anonymous health information for research purposes,
including but not limited to the Banner University Medical Center health network. Studies
may be in any medical area. The scope of future research projects has not yet been
determined. Future studies may be about how genes affect health or respond to treatment.
Studies may require genetic testing. We may also collaborate with industry or provide
samples to industry. All studies will always be conducted in an anonymous fashion.
2. What will happen if I take part in this study?
You will be asked to provide a small amount of saliva in a kit provided by our
collaborative partner, Helix, who performs the genomic testing. At the same time, you
will be asked to complete a very short health questionnaire that can be done on a smart
phone or tablet. The entire process should take about 10 minutes. Signing the consent
will also allow us to anonymously link your medical information to the sample now as
well as in the future.
3. How long will I be in the study?
Your samples will be used and stored indefinitely. There is no limit to the length of time
your information will be stored for future research.
Protocol 1410545697A023 Approved by Univ. of Arizona IRB (Expires 19-Sep-2019)
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4. Can I stop being in the study?
Once samples are in the repository they cannot be withdrawn or destroyed. You can choose
to not have future samples or medical information added to the repository.
5. What risks can I expect from being in the study?
The only risk of participation in the biorepository is accidental disclosure of your medical
information. However, the information is limited and generic. This may result in loss of
your privacy. However, when you sign the consent your sample and health information
will be given a code. The code will only be used to track your samples. The code will
only be known to people who run the repository. However, not even the personnel
working in the repository will be able to link the code with the identity of the sample
donor. We believe the chance these things will happen is extremely small, but we cannot
make absolute guarantees. Your privacy and the confidentiality of your data and
biological samples are very important to us, and we will make every effort to protect it.
6. What are the benefits of participating?
There is no direct benefit to you from your participation at this time, other than access to
your ancestry data. You may be informed of any medical results discovered through
research. However, your participation may help researchers discover new treatments that
may help other people.
7. What other choices do I have if I do not take part in the study?
Your participation in the repository is voluntary. You may choose not to participate.
There will be no penalty or loss of benefits to which you are otherwise entitled.
8. Will my study-related information be kept confidential?
Yes, your samples and health information will be kept confidential. Information will not
be shared with researchers that can directly identify you (unless you give your
permission). All researchers must have IRB approval for human research to obtain your
samples. Your samples and health information will have a code. Researchers will not
have access to the key to the code.
There is a small risk of health insurance discrimination based on genetic testing;
however, per the Genetic Information Nondiscrimination Act of 2008 (GINA), group and
individual health insurers may not use your genetic information to set insurance
eligibility, premiums, or contribution amounts, nor can they request or require that you
take a genetic test. In addition, employers with 15 or more employees may not use your
genetic information to make decisions regarding hiring, firing, job assignments, or
promotions, nor can they request, require, or purchase your genetic information. In Ohio,
there is a similar state law that also provides some protection for private health insurance
plans. GINA does not protect you against genetic discrimination by companies that sell
life, disability, or long-term care insurance.
There may be times when information about you must be released. For example,
information may be disclosed if required by state law. Also, your information may be
reviewed by regulatory offices, such as the Office of Human Research Protections and
the Institutional Review Board.
Protocol 1410545697A023 Approved by Univ. of Arizona IRB (Expires 19-Sep-2019)
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9. Will there be any costs to me?
There will be no costs to you for participating in this study.
10. Will I be paid for taking part in this study?
There is no financial or other form of compensation to you as a result of your
participation, other than your ancestry report. We will use your samples and data for
research purposes only. At times we may provide samples to industry and we will
charge them to recoup our costs. However, your samples may be used to develop drugs
or tests that could be sold by those companies. You will not receive any compensation
from these activities.
11. What are my rights if I take part in this study?
By signing this form, you do not give up any legal rights.
12. Who can answer my questions about the study?
For questions, concerns, or complaints about the study you may contact the Biorepository
Director, David T Harris, Ph.D., 520-626-5127.
For questions about your rights as a participant in this biorepository or to discuss
complaints with someone who is not part of the biorepository team, you may contact the
Human Subjects Protection Program at 520-626-6721 or online at
http://rgw.arizona.edu/compliance/human-subjects-protection-program.
Signing the consent form
I have read (or someone has read to me) this form and I am aware that I am being asked to
participate in a research study. I have had the opportunity to ask questions and have had them
answered to my satisfaction. I voluntarily agree to participate in this study.
I am not giving up any legal rights by signing this form. I will be given a copy of this form.
Printed name of subject Signature of subject
AM/PM
Date and time
Printed name of person authorized to consent for subject
(when applicable)
Signature of person authorized to consent for subject
(when applicable)
AM/PM
Relationship to the subject Date and time
There may be times when it would be beneficial to re-contact you to obtain more information or another sample. Any re-contact would be done by the original person(s) who consented you. If you would object to being re-contacted at some time in the future please initial here.___________
Protocol 1410545697A023